Bleb Dysesthesia Trial
| ISRCTN | ISRCTN22738539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22738539 |
| Secondary identifying numbers | N0203125674; N0199129912; N0176115690 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 29/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr John Salmon
Scientific
Scientific
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised trial of the effect of bleb site on eye comfort following trabeculectomy |
| Study objectives | To investigate long-term post-operative eye discomfort following glaucoma surgery; in particular whether two different wound locations and therefore eye fluid drainage, differ in the level of eye comfort experienced as measured by a validated questionnaire, the 'Glaucoma Symptom Scale'. On 14/07/2011 the following changes were made to this trial record: 1. The end date was changed from 31/12/2008 to 30/06/2010. 2. The target number of participants was changed from 40 to 150. 3. The trial was originally a multi-centre trial but due to recruitment issues at other centres the Oxford site proceeded single-handedly. |
| Ethics approval(s) | Oxford Research Ethics Committee B, 10/09/2002, ref: C02.200 |
| Health condition(s) or problem(s) studied | Surgery: Trabeculectomy |
| Intervention | The study design is a randomised trial designed to compare two accepted variations in surgical techniques of trabeculectomy and its effect on postoperative eye comfort. Patients who are undergoing first trabeculectomy will be approached to participate in the study. Patients will either be recruited in person or by invitation letter. When the patient gives written consent, they are randomised either to superior trabeculectomy or superonasal trabeculectomy. At the pre-operative visit they will answer a 10-question self-administered questionnaire, the Glaucoma Symptom Scale. Some pre-operative data will be collected on study forms identified only by hospital number and study number. During the trabeculectomy, the bleb will be placed below the middle upper lid, or placed below the more inner upper lid. After the trabeculectomy, usual medical care will take place uninfluenced by their participation in this study. At the 6-month post-operative visit, the patient will be examined for the study and a second Glaucoma Symptom Scale questionnaire will be completed by the patient. The examination will record clinical findings such as visual acuity, eye pressure and eye examination findings. The study ends here and patients continue their usual care. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Eye comfort at 6 months post-surgery as measured by the Glaucoma Symptom Scale 2. Eye features associated with eye discomfort (dysesthesia) at 6 months post-surgery |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 10/09/2002 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Aged 18 years and over, either sex 2. Listed for trabeculectomy 3. Satisfy the inclusion criteria |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 10/09/2002 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Royal Devon and Exeter NHS Trust (UK)
No information available
Royal Berkshire and Battle Hospitals NHS Trust (UK)
No information available
Oxford Radcliffe Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
